TriVascular Post-Market Registry

TriVascular

Status: Completed

Conditions: Abdominal Aortic Aneurysm

Treatments: Device: Ovation™ or Ovation Prime™ Abdominal Stent Graft System

Study type: Observational

Funder types: Industry

Identifiers

NCT01372709

771-0008

Details and patient eligibility

About

This is a prospective observational post-market study of subjects receiving the Ovation™ or Ovation Prime™ Abdominal Stent Graft System ("Ovation™ or Ovation Prime™ Abdominal Stent Graft System Post-Market Study") in the treatment of abdominal aortic aneurysms (AAA). The Ovation™ or Ovation Prime™ Abdominal Stent Graft System Post-Market study is intended to expand the clinical knowledge base by collecting data on subjects treated with the Ovation™ or Ovation Prime™ Abdominal Stent Graft System in actual clinical practice following commercial approval.

Enrollment: 501 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subject is > 18 years or minimum age as required by local regulations.
• Indication for elective repair of AAA with an endovascular stent graft in accordance with the Instructions for Use of the Ovation™ or Ovation Prime™ Abdominal Stent Graft System.
• Subject has signed an Ethics Committee (EC) approved Informed Consent Form. The subject or legal representative has been informed of the nature of the study, has consented to participate, and has authorized the collection and release of his/her medical information.
• Subject intends to electively receive the Ovation™ or Ovation Prime™ Abdominal Stent Graft System.
• Subject has the ability and willingness to comply with all follow-up exams as indicated in clinical investigation plan.

Exclusion criteria

• Subject demonstrates high probability of non-adherence to physician's follow-up requirements.
• Subject's current participation in a concurrent randomized control trial (RCT) or investigational device/drug study which could confound study results.
• Life expectancy less than 1 year
• Pregnancy
• Subjects with poor renal function as indicated by a serum creatinine > 2.5mg/dl.

Trial design

501 participants in 1 patient group

Ovation™ or Ovation Prime™ Abdominal Stent Graft System

Description:

Adult male and female patients will be consecutively screened for the study. Eligible patients must meet all of the inclusion criteria and none of the exclusion criteria.

Treatment:

Device: Ovation™ or Ovation Prime™ Abdominal Stent Graft System